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Date: Monday, Sept. 29, 1997
FOR IMMEDIATE RELEASE
Contact: HRSA Press Office(301) 443-3376

HHS Asks for Comments on Recommended Drug Treatments for Infants and Children with HIV


HHS Secretary Donna E. Shalala today announced draft guidelines on tailoring the use of powerful antiretroviral drugs to treat infants, children, and adolescents with HIV. Developed by 64 specialists in pediatric HIV care, family members of HIV-infected children, and federal agency representatives, the proposed guidelines will be published in this week's Federal Register for a 30-day public comment period.

"These guidelines will fill an important gap in our knowledge by recognizing the unique treatment needs of infants, children and adolescents living with HIV," said Secretary Shalala. "With early testing and aggressive treatment, infected children will live longer, more normal lives." Last June, HHS and the Kaiser Family issued draft guidelines for antiviral treatments of adults with HIV. The final guidelines will be published shortly.

The guidelines were developed by the Working Group on Antiretroviral Therapy and Medical Management of HIV Infected Children, which was convened in July 1997 by the National Pediatric and Family HIV Resource Center.

The working group was co-chaired by Dr. James Oleske, University of Medicine and Dentistry of New Jersey, New Jersey Medical School, and Dr. Gwendolyn Scott, University of Miami, Florida, and sponsored by the Health Resources and Services Administration (HRSA). HRSA is the Federal Agency responsible for providing access to HIV-related care through the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, a $1 billion a year program serving those who would otherwise be unable to receive treatment.

As most HIV infection in children is acquired by transmission of virus from mother to child, there are many unique issues for caring for children born to HIV-infected women. The majority of perinatal transmission occurs shortly before or during birth. The working group believes that by using sensitive viral tests, most infected newborns can be identified by one month of age, and virtually all by 6 months of age. HIV perinatal infection also occurs during the time that the infant's immune system is immature and developing. Consequently, how the disease manifests and progresses varies substantially from that of an adult. Disease progression appears more rapid among infected children than adults, and viral levels in the blood remain persistently elevated in many perinatally-infected children for prolonged periods. Therefore,

most working group participants would initiate combination antiretroviral therapy in all HIV-infected infants under 12 months of age as soon as a confirmed diagnosis is established. The working group recommends that therapy be initiated with potent combination antiretroviral drug regimens similar to those recommended in infected adults. Two protease inhibitors (ritonavir and nelfinavir)

with pediatric formulations have recently been approved by the Food and Drug Administration for use in children.

According to Joseph F. O'Neill, M.D., M.P.H., Associate Administrator of HRSA's HIV/AIDS Bureau, an important concept in formulating these guidelines was that "appropriate treatment of HIV-infected infants depends upon the identification of HIV-exposed infants as soon as possible. Thus, it is critical to identify HIV-infected women before or during pregnancy, and it is critical that these women and their newborns receive care directed by health care providers with extensive experience in HIV care."

The panel also developed recommendations for treatment of older infants and children as well as adolescents. Group co-chair

Dr. James Oleske emphasized, "adult guidelines are more appropriate for older adolescents, but youth in their growth spurt or younger may be more appropriately treated using the pediatric guidelines." Dr. Gwendolyn Scott, the second chair, explained that the group's intent is that the guidelines, when published in final form, "be regarded as flexible and not supplant the clinical judgement of experienced health care providers. As research continues, and our knowledge grows, these guidelines will need to be modified." The group also recommended that all antiretroviral drugs approved for treatment of HIV infection be available for use in children, irrespective of labeling notations.

Comments on the proposed guidelines must be received by HRSA on or before Oct. 30 to ensure that all comments are considered in preparing the final guidelines. Submit written comments to: The HIV/AIDS Treatment Information Service, P.O. Box 6303, Rockville, MD 20849-6303. Only written comments will be accepted. After consideration of the comments, the final document will be published in the Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report.

Copies of the Guidelines are available from the National Aids Clearinghouse (1-800-458-5231), Website (www.cdcnac.org); and from the HIV/AIDS Treatment Information Service (1-800-448-0440; Fax: 301-519-6616; TTY: 1-800-243-7012), Website (www.hivatis.org).


Note: HHS press releases are available on the World Wide Web at: www.hhs.gov.